Spironolactone

Product NDC: 63629-2438
11-digit product format: 636292438
Labeler code: 63629
Product ID: 63629-2438_dca8fb3f-0258-4cc5-b4c6-4ac3bc31f1de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203253
Marketing category: ANDA
Marketing start: 2013-02-01
Substance: SPIRONOLACTONE
Active strength: 50 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203253-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23
A203253-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23
A203253-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203253-001	AB
A203253-002	AB
A203253-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203253-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Spironolactone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SPIRONOLACTONE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
27O7W4T232	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198223	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d335cba1-5b36-51c8-120a-594ec9d05330	Product name	5	20251114
25f5e2cf-3572-477b-994c-aa692751e5a8	Product name	2	20250616
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-2438-1	Spironolactone	100 in 1 BOTTLE	TABLET, FILM COATED	100		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2438-1	EA - Each	63629-2438	73b7b485-64db-4cc9-a9bb-990e467736b7	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2438	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 1 package rows	20240817_9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	6518ba72-89e4-4f2f-b334-9ef759b696f8	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	QPharma, Inc.	37066684-5b63-4d3e-ae6a-08c4b3edd7aa	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	37b9bc61-2757-454a-935b-752d13eb7eb4	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	b5b129b8-aed9-4d94-a35e-e92647effbdb	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	574efac6-b2d9-4053-940c-552f01a69b2e	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 63629-2438
Spironolactone	SPIRONOLACTONE	Jubilant Cadista Pharmacuticals Inc.	c1c5fdab-3ff7-414b-8e25-beed8311b8ad	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Jubilant Cadista Pharmacuticals Inc.	a7510768-8a52-4230-6aa0-b0d92d82588f	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	5c2ae130-8e84-4c3f-b190-82691312fcbd	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	caf9c845-63eb-40bd-8261-0582abdf705a	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
27O7W4T232	SPIRONOLACTONE	52-01-7	SPIRONOLACTONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198223	spironolactone 50 MG Oral Tablet	PSN	9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1	103
198223	spironolactone 50 MG Oral Tablet	SCD	9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2438-1	63629243801	100 TABLET, FILM COATED in 1 BOTTLE (63629-2438-1)	2017-04-04	0000-00-00	No	No	Current